CQV Engineer

DPS Group Global; Dublin; On-site; EUR 65,000 - 90,000; Full time

Job summary

Arcadis Ireland is seeking a CQV Engineer to lead formulation and component preparation activities for a sterile drug product facility. You will develop and execute CQV documentation for equipment, manage FAT testing, and ensure compliance with EU/FDA regulations and GMP standards throughout commissioning and qualification.

The role requires a BS in a scientific/engineering field with at least 5 years in the pharmaceutical industry, and demonstrated ability to work in matrix teams to deliver CQV

Qualifications

• Demonstrated CQV testing capacity from initiation to completion.
• CQV lifecycle experience from design through C&Q and handover.
• Experience working in a matrix team of CQV professionals to deliver tasks on time and within budget.
• Experience with CQV of sterile manufacturing equipment with integrated automation.
• Experience with single-use mixers, TCUs, utility panels, filtration systems, autoclaves, washers, and powder-handling equipment.

Responsibilities

• Development and execution of CQV testing documentation for equipment in the sterile drug product facility.
• Meeting key project deliverables for safety, CQV schedule and quality of project documentation.
• Ensure GMP equipment are tested in compliance with GMP and EU/FDA regulations.
• Ensure non-GMP equipment are tested in line with commissioning standards.
• Deviation and risk management for assigned equipment and utilities.
• Execute FAT testing and apply results into the qualification process.
• Ensure training is completed on time to meet site metrics.

Skills

CQV testing

FAT testing

Sterile drug product

Documentation

Risk management

Communication skills

Teamwork

Education

BS in science/engineering

Tools

Automation systems

Qualification software

Job description

CQV Engineer Formulation & Component Prep

• Development and execution of CQV testing documentation for Equipment for the Sterile Drug product facility.
• Responsible for meeting key project deliverables for safety, CQV schedule and quality of project related documentation/electronic records for equipment assigned.
• Responsible for ensuring GMP equipment are tested in compliance with good manufacturing practices, company policies and EU & FDA regulations.
• Responsible for ensuring that all non GMP equipment, are tested in compliance with project related standards from a commissioning perspective.
• Deviation management associated with the assigned equipment and utilities.
• Risk Management Identifies and categorizes CQV risks according to impact on commissioning and qualification. Generation of action plans to mitigate qualification risks.
• Execution of FAT testing and leveraging results into overall qualification process for assigned equipment, facilities and utilities.
• Ensuring all assigned training is executed on time to meet site metrics.
• Demonstratable capacity to effectively execute the CQV testing approach for assigned from initiation to completion.
• CQV project lifecycle experience from design through to C&Q and handover.
• Demonstrable experience of performing as part of diverse team of CQV professionals/ contractors to deliver on tasks safely, with quality focus, on time and within budget.
• Experience in CQV of Drug Substance/Drug product sterile manufacturing equipment with integrated automation.
• Specifically experience with CQ of Single Use Mixers & TCUs, Utility Panels & Filtration Systems (TFF), Autoclaves, Parts Washers and Powder Handling equipment such as Blenders and Jet Mills.
• Solid background of document preparation, execution, and task planning on CQV projects with a demonstrated record of on time performance.
• Excellent communication skills and the ability to influence others.
• Demonstrative experience working in teams in a matrix environment to deliver CQV elements.

Responsibilities

• Development and execution of CQV testing documentation for Equipment for the Sterile Drug product facility.
• Responsible for meeting key project deliverables for safety, CQV schedule and quality of project related documentation/electronic records for equipment assigned.
• Responsible for ensuring GMP equipment are tested in compliance with good manufacturing practices, company policies and EU & FDA regulations.
• Responsible for ensuring that all non GMP equipment, are tested in compliance with project related standards from a commissioning perspective.
• Deviation management associated with the assigned equipment and utilities.
• Risk Management Identifies and categorizes CQV risks according to impact on commissioning and qualification. Generation of action plans to mitigate qualification risks.
• Execution of FAT testing and leveraging results into overall qualification process for assigned equipment, facilities and utilities.
• Ensuring all assigned training is executed on time to meet site metrics.

Required Competencies

• Demonstratable capacity to effectively execute the CQV testing approach for assigned from initiation to completion.
• CQV project lifecycle experience from design through to C&Q and handover.
• Demonstrable experience of performing as part of diverse team of CQV professionals/ contractors to deliver on tasks safely, with quality focus, on time and within budget.
• Experience in CQV of Drug Substance/Drug product sterile manufacturing equipment with integrated automation.
• Specifically experience with CQ of Single Use Mixers & TCUs, Utility Panels & Filtration Systems (TFF), Autoclaves, Parts Washers and Powder Handling equipment such as Blenders and Jet Mills.
• Solid background of document preparation, execution, and task planning on CQV projects with a demonstrated record of on time performance.
• Excellent communication skills and the ability to influence others.
• Demonstrative experience working in teams in a matrix environment to deliver CQV elements.

Required Qualification(s) And Desired Experience

• The ideal candidate should hold a minimum of a BS qualification (Degree) in a scientific, technical or engineering discipline along with a minimum of 5 years of experience within the pharmaceutical industrial ideally with familiarity with Sterile Drug Product filling line experience.

About Arcadis

Arcadis is the world's leading company in sustainable design, engineering, and consultancy for natural and built assets. With over 36,000 professionals across more than 70 countries, we are united by a common purpose: improving quality of life through innovation, collaboration, and sustainable solutions.

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Why Join Arcadis?

At Arcadis, we empower individuals to excel because your contributions matter. Taking a skills-based approach, we provide opportunities for you to shape your career, maximise your impact, and grow professionally.

By joining us, you'll engage in meaningful work that helps deliver sustainable solutions for a better planet while leaving a lasting legacy for future generations.

Our Commitment to Equality, Diversity & Inclusion

We are dedicated to creating an environment where everyone can thrive. Through our six ED&I workstreams: Age, Disability, Faith, Gender, LGBT+, and Race, we foster innovation by bringing together diverse perspectives and experiences. Together, we strive to improve quality of life while building a more inclusive future for all.

Join Arcadis. Create a Legacy.